Registration Dossier

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2015-11-20 to 2015-11-27
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report Date:
2016

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Test system

Vehicle:
physiological saline
Controls:
yes, concurrent vehicle
yes, concurrent positive control
Amount / concentration applied:
750 µL (i.e. 150mg/750µL) of test item, negative or positive control
Duration of treatment / exposure:
240 minutes
Number of animals or in vitro replicates:
in vitro: triplicate design

Results and discussion

In vitro

Resultsopen allclose all
Irritation parameter:
in vitro irritation score
Run / experiment:
run 1
Value:
113.9
Vehicle controls valid:
yes
Negative controls valid:
yes
Positive controls valid:
yes
Remarks on result:
positive indication of irritation
Irritation parameter:
cornea opacity score
Run / experiment:
run 1
Value:
62.2
Vehicle controls valid:
yes
Negative controls valid:
yes
Positive controls valid:
yes
Irritation parameter:
fluorescein leakage
Run / experiment:
run 1
Value:
3.45
Vehicle controls valid:
yes
Negative controls valid:
yes
Positive controls valid:
yes

Any other information on results incl. tables


Opacity
Permeability
IVIS
per cornea
per group
(mean value)
SD
Negative Control
0.9 % NaCl Solution
-0.062
-0.001
-0.082
0.8
0.9
1.816
-0.001 1.801
0.706
-0.001 0.696
Positive Control
20 % Imidazole  solution
70.793
2.142
102.928
106.6
4.1
71.315
2.303
105.860
79.270
2.119
111.060
Test material
20% suspension
66.507
3.447
118.217
113.9
16.4
72.337
3.699
127.827
47.660
3.206
95.780



Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
Under the given experimental conditions the test material the test material has ocular corrosive potential.
Executive summary:

This study was performed according to GLP and the methods applied are fully compliant with OECD TG 437. The test material was corrosive in this in vitro assay.